“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and puerto rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”                                                        

Top 3 Must Have Skills        

• A minimun of a BS degree w/ 5 years of directly related experience (manufacturing or quality experience)
• Must have CMC-specific regulatory knowledge & experience with product lifecycle changes impacting CTAs and MAs, including biologics and small molecules
• Organized, able to multitask, and have a track record of completing deliverables on time with high quality
• Excellent communication (both written and verbal), presentation and facilitation skills

Day to Day Responsibilities:    

• Assess change controls for reportability
• Assess manufacturing deviations for reportability
• Gather country specific documents for submissions

"This posting is for Contingent Worker, not an FTE"